06.12.24

Durbin Questions FDA, DOJ On Allowing Sale Of Unauthorized Vaping Products During Senate Judiciary Committee Hearing On Prevalence Of Youth E-Cigarette Use

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, today questioned witnesses during a Senate Judiciary Committee hearing entitled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use—including the role of the tobacco industry in flooding the market with kid-friendly, flavored vaping devices —and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.

Durbin first questioned Arun Rao, Deputy Assistant Attorney General of the Consumer Protection Branch in the Civil Division of the Department of Justice (DOJ), and Dr. Brian King, Director of the Center for Tobacco Products at the Food and Drug Administration (FDA) about why FDA and DOJ have failed to crack down on the sale of unauthorized e-cigarette products.

“Under the Tobacco Control Act, a manufacturer has the burden of proving to FDA that its e-cigarette is ‘appropriate for the protection of public health’ before it can enter the market.  In other words, unless the manufacturer meets its burden and the FDA authorizes the product, it is illegal for that e-cigarette to be sold in the United States,” Durbin began.  “To date, FDA has authorized only 23 e-cigarettes, and no flavored e-cigarettes have been authorized by FDA.”

Sharing photos of several vaping products sold in a shop less than one mile from FDA’s headquarters, Durbin asked, “Not a single one of these products has been authorized by FDA.  None of them.  These illegal products—clearly designed for kids by their flavors—are being sold in the shadow of FDA’s headquarters.  How is that allowed to happen?”

Dr. King said that the volume of premarket tobacco product applications (PMTAs) is overwhelming, so FDA instead prioritizes its enforcement duties when it comes to e-cigarette products.

Durbin rebuffed Dr. King’s answer by saying, “You have completely fallen down on the job. Your responsibility is to impose the burden of proof and not allow the sales of these e-cigarettes to kids unless they were approved by FDA, correct?”

Dr. King agreed and tried to argue that the number of PMTAs that have been filed makes it difficult for FDA to review applications despite the agency being nearly three years past a court-mandated deadline. 

Durbin pushed back, noting, “They [e-cigarette manufacturers] have to prove they are appropriate for public health.  You don’t have to disprove.” 

Dr. King reiterated that the volume of applications is the source of the delays.

“If I file legal briefs thick enough, I can go ahead and sell my product without approval?” Durbin asked. 

Dr. King replied that each product must be reviewed through a lengthy scientific process.

Durbin then questioned Mr. Rao about the delayed PMTA reviews, despite a deadline of September 9, 2021, ordered by the U.S. District Court for the District of Maryland for FDA to complete PMTA reviews.  “Thirty-three months. Thirty-three months since the Maryland court said you are required through FDA to get your job done and nothing has happened. You call this an urgent need. What is urgent about waiting almost three years and doing nothing?” Durbin asked.

Mr. Rao answered that he shares Durbin’s concerns and believes in aggressively enforcing this law.

“So what should we do as a nation to say to them [e-cigarette manufacturers] you cannot, in this situation, openly defy the law and the agencies and sell your product to children? What is it we should do to stop them?” Durbin asked.

Mr. Rao replied that DOJ should signal that they will aggressively enforce the law in this situation.

“I am sorry.  I am against signals.  Do something!” Durbin urged.  “To announce… days before this hearing that you’re going to have real law enforcement get involved in this, what in the hell have you been waiting for?”

“You’re failing.  You are failing within a mile of the headquarters. There’s evidence that you are failing. What’s serious about this is not only the failure of the attorneys, but the failure that is leading to the addiction of children,” Durbin said. 

Citing the newly announced multiagency task force to combat the illegal distribution and sale of e-cigarettes, Mr. Rao expressed his optimism that the new partnerships will yield results.

“It has been quite a few years since I finished my law school courses, but I believe I understand the burden of proof.  They [e-cigarette manufacturers] have the burden of proof.  They have failed to meet it and are selling their product regardless.  Our government, the Department of Justice, and FDA stand by and say ‘this is too complicated.’  It’s not complicated.  It’s basic.  If they have the burden of proof and have not met that, they are violating the law,” Durbin concluded his questioning of the first panel. 

Video of Durbin’s questions for the first panel in Committee is available here.

Audio of Durbin’s questions for the first panel in Committee is available here.

Footage of Durbin’s questions for the first panel in Committee is available here for TV Stations.

Durbin then began his questioning of the second panel of witnesses by asking Tony Abboud, Executive Director of the Vapor Technology Association, a national trade association for the vaping and alternative nicotine products industry, about Ms. Josie Shapiro’s experience becoming addicted to nicotine from vaping as a high school student.

“Mr. Abboud, when you listen to Ms. Shapiro talk about her addiction, what did you think as head [of the Vapor Technology Association]?... Do some of your kids vape?” Durbin asked. 

Mr. Abboud replied that he thinks about this issue as a father.  He confirmed that some of his own children use e-cigarettes.

“Do you encourage them to stop?” Durbin followed up.

Mr. Abboud affirmed that he does encourage his children to stop vaping.

“You don’t want your kids doing this. Why do we want any kids doing this?” Durbin asked.

Mr. Abboud argued that his organization does not want children to use their products, and the organization was an advocate for raising the age of purchasing tobacco from 18 to 21.

“Your retailers, what do they think about the product?  Do they assume that since it is going to be apparently legally sold in the United States that they have no moral obligation to kids buying them?” Durbin asked David Spross, Executive Director of the National Association of Tobacco Outlets, a national trade association of tobacco retailers.

Mr. Spross replied that these retailers have a zero-tolerance policy to prevent tobacco sales to youth.

“Do your retailers sell flavored products?” Durbin asked Mr. Spross.

Confirming that the association’s retailers do sell flavored products, Mr. Spross pointed to FDA as the source of allowing flavored products to stay on shelves, despite clear statements from FDA that there are only 23 e-cigarettes legally authorized to be sold.  Mr. Spross agreed that e-cigarette manufactures have the burden of proof in proving that their products are acceptable for public health.

“I think the bottom line is, if you want to discourage your own children from using vaping products, we ought to understand the danger of that product.  I think you inherently do.  I think most parents would,” Durbin said to Mr. Abboud as he concluded his questioning. 

Video of Durbin’s questions for the second panel in Committee is available here.

Audio of Durbin’s questions for the second panel in Committee is available here.

Footage of Durbin’s questions for the second panel in Committee is available for here TV Stations.

Durbin has repeatedly called on FDA and DOJ to better enforce federal laws against the unlawful sale of unauthorized e-cigarette products. Durbin has slammed FDA for its continued lack of urgency as millions of children have begun using addictive e-cigarettes. For years, FDA has failed to regulate e-cigarettes—currently falling more than two and a half years past a court-ordered deadline to review applications from vaping companies, and refusing to enforce the law and take action against companies marketing illegal vaping products to children. Under the Tobacco Control Act (TCA), e-cigarette companies are required to obtain authorization from FDA prior to entering the market, which the agency has neglected to properly enforce.

In April, Durbin called FDA and DOJ officials into his Washington office to receive a briefing on the lack of enforcement against unauthorized e-cigarettes that is allowing millions of children to get hooked on nicotine. In the meeting, Durbin questioned the agencies about the unacceptable delay in reviewing pre-market tobacco product applications (PMTAs) and raised concerns about the inadequate efforts to regulate these products despite statutory and court-ordered directives.

Last year, Durbin’s office examined FDA’s public data files to identify e-cigarette manufacturers who have received both marketing denial orders and warning letters yet continue to sell unauthorized products, in order to assess FDA’s effectiveness in taking enforcement action against some of the most flagrantly defiant examples. Durbin’s office found at least 22 vaping products that appeared to be sold online by the manufacturer in violation of the law and in defiance of repeated enforcement actions by FDA. In addition to those products sold online by the manufacturer, several other such products remain available for purchase from third-party retailers, including one of the most popular e-cigarettes among children, Breeze Smoke. Durbin’s investigation also found that FDA has only issued “closeout letters” to 10 percent of the 685 tobacco warning letters it has issued since January 1, 2021. A closeout letter indicates that FDA has verified that corrective action has taken place to address the violations contained in the warning letter.

Durbin has been a vocal leader in the fight against Big Tobacco, particularly since he lost his father to lung cancer when Durbin was 14. He went after Big Tobacco when he served in the House of Representatives and led the charge to ban smoking on airplanes, which eventually led to restaurants, office buildings, trains, and much more. Durbin has also led efforts to grant FDA jurisdiction over tobacco, raise tobacco taxes to prevent youth initiation, and enhance support for tobacco cessation tools.

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